Competence Enhancement through collaborations in clinical studies, regulatory, health economics & reimbursement
| Reference number | |
| Coordinator | IAROCA AB |
| Funding from Vinnova | SEK 200 000 |
| Project duration | May 2025 - November 2025 |
| Status | Completed |
| Venture | Medtech4Health: Competence Enhancement in SME |
| Call | Medtech4Health: Competence Enhancement in Small Businesses 2025 |
Important results from the project
The goal of the project has been an increased internal understanding of clinical studies, regulatory and reimbursement, through collaboration between Acorai and Key2Compliance. Through the expertise of Key2Compliance, we have further developed our processes in clinical studies and regulatory, including strategic roadmap and competitive analysis. Competence transfer has taken place: 1) Workshops by Key2Compliance, 2) Collaborations between Key2Compliance and Acorai; meetings and discussions.
Expected long term effects
Thoroughly worked out results of CAPTURE-HF (previous clinical study), and preparations for upcoming studies in 2026. Further work with FDA & CE mark, and work with EU AI Act and how this will affect Acorai. Long-term effects of the project are increased internal competence, better preparations for upcoming steps and increased collaboration between Acorai and Innokas Medical in Finland, who with their expertise will take greater responsibility for QARA issues in the future.
Approach and implementation
The project has been done in two work packages; 1) clinical studies, and 2) regulatory work. The implementation has been carried out through continuous meetings between Acorai and Key2Compliance, with division of project tasks. Knowledge transfer has taken place through close collaboration and two workshops. The final products of the project have been reported by Key2Compliance, where the focus has been on clinical preparation, regulatory preparatory work and reimbursement opportunities.